Quality Management Systems

42 Technology provides practical assistance in the development and improvement of Quality Management Systems compliant with international standards such as ISO9000, ISO13485, and US FDA cGMP requirements.

We believe strongly in putting systems in place that are simple, user friendly and focused on true quality objectives – improving customer satisfaction and reducing waste.

Whether it is providing an impartial external audit, implementing corrective action programs in response to known problems, or simplification of over-complex systems which are not satisfying business needs, we will work constructively with your team to make valuable improvements.

Regulatory Approval

We will help with CE marking and other regulatory approvals, particularly for electronic systems.

In the field of Medical Devices, we offer assistance with CE marking and the preparation of US (PMA, 510(k)) regulatory submissions.

Risk Management

Our engineers are experienced in leading risk management activities to comply with latest regulatory requirements in a number of product areas.

Process Validation

42 Technology will manage and execute process and computer system validation activities to FDA standards for new and existing manufacturing equipment and processes. We are able to supply all of your resource requirements in this area, including project managers, protocol creators and protocol executors.